Yes. We have invested over 40 million dollars in research, clinical studies and facilities to develop and test our human milk derived products. This world class research and development would not have been possible in a non-profit business model.

Prolacta has set up a network of affiliated milk collection organizations. These organizations can be found in hospitals, birthing centers, or associated with charities. Depending on the organization, they share the responsibilities of qualifying the donors and collecting the milk with Prolacta. All affiliated milk collection organizations have all milk sent to Prolacta for processing.

The milk that is collected through affiliated milk banks is tested, pasteurized and formulated into nutritional products exclusively for in hospital use. The formulations are made specifically to feed critically ill premature babies that are in the NICUNICU
Neonatal/Newborn Intensive Care Unit.. The donations do not serve as substitutes for mother’s milk if a baby is not under hospital care.

Yes. Prolacta products are regulated by the FDA. Prolacta’s facility is licensed as a tissue bank by the states of California, New York and Maryland, which require such a license for human milk banking.

Breast milk donations follow a rigorous screening process based on the blood banking model. Prolacta is the only organization that uses these combined safety steps:

Potential breast milk donors are screened through a medical history survey. After the screening, the donor is entered into Prolacta’s secure database and assigned a donor number.

Once the potential donor passes the medical history survey, she must obtain written approval from her physician and her baby’s pediatrician before she can continue in the donation process.

The potential donor measures the temperature in her freezer with a thermometer provided by Prolacta. The temperature must be cold enough to store human milk or, unfortunately, the potential donor may not donate.

If the potential donor passes the screening and meets all of the requirements outlined above, she is qualified to be a breast milk donor for a four month period. After four months, if she wishes to continue donating, she must complete a new medical history survey and have another blood test.

When we first began co-promoting Prolacta products, both companies had relatively small product portfolios for premature babies. Over the years, both of our businesses have grown and we both now have extensive portfolios of products. To provide the best service to our customers, both companies decided it was best to focus on supporting their respective portfolios.

If you have excess breast milk, you can donate it to be processed into specialty formulations and sold to hospitals to help meet the nutritional needs of critically ill premature infants in neonatal intensive care units. Many moms donate their extra milk to help babies in need because they have had a preterm baby in the past or know someone who has had that experience. Breast milk donors report a sense of satisfaction knowing they are providing their milk to help provide the added nutritional needs to sick premature infants.

The DNA matching step is necessary so that the milk we receive is matched to our qualified donors. This safety step ensures that only milk from qualified moms is accepted for production.

We start by having the prospective donor provide a sample of cheek cells that we can use to create a unique Donor ID. We extract the DNA from the cheek cells and use it to create a series of 32 numbers that are unique to that donor. Only identical twins share the same profile. Two of the numbers in the profile tell us whether the DNA comes from a man or a woman.

Once the donors milk arrives, we take a sample of the DNA found in the milk and generate a Milk ID. We then look to make sure that the Donor ID and Milk ID profiles match. We can also see if there are multiple Milk ID profiles in the same donation, indicating there are two or more different mothers’ milk is contained in the donation.

The only information that we generate about the donor from her DNA are the Donor and Milk IDs. We do not generate any other genetic information about the donor. The Donor ID contains no information about the donor’s health or heredity. Prolacta does not retain samples of the donor’s isolated DNA once the matching of donor to donation is complete. The only thing that is retained is the 32 number Donor ID.

While there are other ways to match a donor to a tissue sample, this technique is considered the most accurate and is the gold standard.